Regulatory Open Forum

Hello everyone,

I would like to know how we can send complaints of a medical device to competent authorities in France, Netherlands, and the UK. Are there any specific ways and requirements to do so? Is there any database that we can use? If yes, how we can get that?

Any feedback would be appreciated.

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FATEME FARMAD
Quality and Regulatory Affairs Associate
Minnetonka MN
United States
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The EU regulations don't require you to send complaints to competent authorities. Receive the complaints and process them following your documented method. Using the definitions from the regulation classify each complaint as an incident or not. For each incident, classify it as serious or not. Report serious incidents through Eudamed. Add non-serious incidents to information for trend analysis. If the trend analysis generates a signal, then report through Eudamed.

Eudamed is designed to route these reports to the correct Competent Authorities, so you just need to enter them.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 05-Oct-2021 16:15
From: FATEME FARMAD
Subject: Reporting medical device complaints to Europe competent authorities

Hello everyone,

I would like to know how we can send complaints of a medical device to competent authorities in France, Netherlands, and the UK. Are there any specific ways and requirements to do so? Is there any database that we can use? If yes, how we can get that?

Any feedback would be appreciated.

------------------------------
FATEME FARMAD
Quality and Regulatory Affairs Associate
Minnetonka MN
United States
------------------------------

As stated by Dan, you don't need to send the complaints. But if you are asking about sending Field Safety Corrective Action and Field Safety Notice, perhaps you should contact your EU Authorized Rep. As of now FSCA/FSNs are being exchanged via email. When the Vigilance module of EUDAMED will go online, you shall be able to upload it directly to the EUDAMED.

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Monoj Mon Kalita, PhD
Senior RA Specialist
New Taipei City
Taiwan
------------------------------

Original Message:
Sent: 05-Oct-2021 16:15
From: FATEME FARMAD
Subject: Reporting medical device complaints to Europe competent authorities

Hello everyone,

I would like to know how we can send complaints of a medical device to competent authorities in France, Netherlands, and the UK. Are there any specific ways and requirements to do so? Is there any database that we can use? If yes, how we can get that?

Any feedback would be appreciated.

------------------------------
FATEME FARMAD
Quality and Regulatory Affairs Associate
Minnetonka MN
United States
------------------------------

You can find the incident reporting form here:
https://ec.europa.eu/docsroom/documents/41681

You can find the email addresses to send it to in this list of vigilance contact points:
https://ec.europa.eu/health/md_sector/contact_en

As Manoj mentioned, your EC REP may be a good resource, particularly if your agreement allows or requires them to submit reports on your behalf.

I'd recommend updating your procedures with appropriate requirements and instructions so you can be ready to send reports promptly when required.

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Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 05-Oct-2021 22:12
From: Monoj Kalita
Subject: Reporting medical device complaints to Europe competent authorities

As stated by Dan, you don't need to send the complaints. But if you are asking about sending Field Safety Corrective Action and Field Safety Notice, perhaps you should contact your EU Authorized Rep. As of now FSCA/FSNs are being exchanged via email. When the Vigilance module of EUDAMED will go online, you shall be able to upload it directly to the EUDAMED.

------------------------------
Monoj Mon Kalita, PhD
Senior RA Specialist
New Taipei City
Taiwan

Original Message:
Sent: 05-Oct-2021 16:15
From: FATEME FARMAD
Subject: Reporting medical device complaints to Europe competent authorities

Hello everyone,

I would like to know how we can send complaints of a medical device to competent authorities in France, Netherlands, and the UK. Are there any specific ways and requirements to do so? Is there any database that we can use? If yes, how we can get that?

Any feedback would be appreciated.

------------------------------
FATEME FARMAD
Quality and Regulatory Affairs Associate
Minnetonka MN
United States
------------------------------